Pharmacokinetics (PK) Drug Interaction Study of Milademetan and Itraconazole or Posaconazole in Healthy Participants
Status:
Completed
Trial end date:
2018-10-01
Target enrollment:
Participant gender:
Summary
This will be an open-label, randomized, 3-treatment, 2-period, 2-sequence study in healthy
subjects to evaluate the single-dose PK of milademetan when given as monotherapy and when
administered with steady-state levels of the strong CYP3A4 inhibitors itraconazole or
posaconazole.
The duration of the study for each individual subject will be approximately 49 days from the
start of Screening through Study Discharge. Subjects will remain in-house for up to 23 days,
including 22 overnight stays.